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The FDA has introduced models intended to accelerate rare disease drug development, but recent reversals of guidance from the agency speak to a lack of clarity in its implementation. AI can help focus this process.
European pharma companies splashed billions of dollars into the U.S. biopharma sector in a matter of days, but there are differing views on whether the activity represents the rise of a new buyer class or a quirk of timing.
Three pharma CEOs joined the $30 million compensation club in 2025 but Eli Lilly’s David Ricks exceeded his nearest peer by more than $4 million.
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The Department of Health and Human Services is spinning its wheels, unable to establish steady leadership at three major divisions—the CDC and the FDA’s two primary review units.
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Curie.Bio launched this week with $520 million to take early startups from ground zero through Series A funding.
Enveda’s primary R&D efforts will focus on inflammation, fibrosis and neurosensory biology within the GI, dermatology and pulmonary therapeutic areas.
The COVID-19 research collaboration between Vir Biotechnology and GSK has largely come to an end, as Vir announced Monday it would be going it alone or with other partners.
The FDA has rejected Soligenix’s NDA for HyBryte (synthetic hypericin), a therapeutic developed to treat early-stage cutaneous T-cell lymphoma.
The Pregnant Workers Fairness Act (PWFA) has been praised by many in the life sciences who see it as a step forward in protecting the rights of pregnant employees.
Fresh off of his Sanofi exit, John Reed is joining Johnson & Johnson, where he will serve as executive vice president, pharmaceuticals, R&D.
Vivek Ramaswamy, the founder of Roivant Sciences, is officially running for president, the GOP hopeful announced Tuesday.
Clene, Inc. posted new data from a Phase II trial of CNM-AU8 in multiple sclerosis featuring MRI results it claims reinforce neurological improvements reported in November 2022.
Bristol Myers Squibb and 2seventy bio published positive results Friday from a pivotal Phase III trial of Abecma in multiple myeloma patients who had received two to four prior lines of therapy.
Sanofi’s global head of R&D, John Reed, is leaving his position to pursue another opportunity outside the company, the French multinational announced Monday.